RU2721297C2 - Holder of trocar - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: invention relates to device for arrangement and retention of trocar in required position through patient's body walls. Device of trocar holder to support trocar has a trocar barrel, while the trocar travels through the wall of the patient's body, comprises a separate element enabling attachment to the trocar, and comprises a stop element, at least one inflatable element. Anvil member is shaped to fit on outer surface of trocar tube. Fixing element is arranged with possibility of alignment in longitudinal direction along trocar tube for location in selected position. At least one inflatable element extends around the trocar barrel, which can be inflated to the specified size by means of a fluid source. At least one inflatable member is configured to be mounted on the trocar barrel in a position spaced from the anvil member, so that at least one inflatable element in the blown condition could be placed on the trocar tube through the incision in the body wall and could be inflated when fitted to engage with the inner wall surface of the body and so that the support element can be shifted into position to support body wall between said support element and at least one inflatable element. Fluid medium source is configured to provide a fixed volume allowing pumping up to a predetermined size. Fluid medium source comprises manually compressible pump arranged on trocar barrel. Pump comprises a retainer configured to hold the pump in a compressed state to maintain pumping unless extraction is required until the retainer is unlocked. Spring is provided to reverse the pump and to withdraw fluid from the inflatable member when unlocking the retainer.

EFFECT: use of the invention enables maintaining the trocar in the desired position during medical procedures.

8 cl, 12 dwg

Description

This invention relates to a device for placing and holding a trocar in position through a wall of a patient.

State of the art

Many documents of the prior art offer designs in which the trocar (or other device for penetrating through the wall of the body) is held in place by a stop on the outside and an inflatable balloon on the inside.

US Patent 3,253,594, issued in 1966 to Matthews, describes a preliminary design of this type (called the "abdominal cannula"), which has a flat washer on the outside, which forms a stop that is fixed with a screw, and an inflatable balloon on the inside. The specified balloon is inflated by supplying saline from an external source through a channel, which is a simple tube, which may or may not have a circular cross section.

US patent 4,861,334, issued in 1989 to the Nawaz author, describes a more efficiently designed structure of this type, called a “gastrostomy tube”, which has a domed washer on the outside that is fixed with a screw and an inflatable balloon on the inside. The specified cylinder is pumped through a channel in the inner part of the tube into which air is supplied from an external source through an external inlet.

Many subsequent patents are cited as design improvements by Nawaz.

In a number of published patent applications, Applied Medical Resources (“Albrecht et al.”) Discloses that it is known to attach an inflatable cuff to a trocar. For instance:

US patents US 2007/0239108 and US 2007/0213675 declare a tube in the form of a cannula with a balloon, but are limited to the use of annular grooves and a longitudinal channel to provide communication with the possibility of transferring fluid from the inlet to the balloon;

US patent US 2009/0221960 claims the first and second inflatable sections or cylinders and the inlet. This document mentions that the locking device can be formed as a separate module for attachment to an existing trocar. This idea is not new.

U.S. Patent US 2010/0081994 to Zisow provides an articulated end portion of a trocar tube that rotates to counteract trocar removal.

It turns out that Telflex Medical and Applied Medical Resources both have related products and a significant number of previous patents, but no additional patents or patent applications have been filed that directly relate to this issue.

All publications, patents, and patent applications referred to in this description are incorporated herein by reference to the same extent as if each individual publication, patent, or patent application were specifically and individually indicated to be incorporated herein by reference, or may be mentioned for the purpose of any further details of such devices.

SUMMARY OF THE INVENTION

One object of the present invention is to provide a trocar holder that can be used together with an existing trocar to assist in holding said trocar in position during medical procedures.

In accordance with one aspect of the present invention, there is provided a trocar holder device for supporting a trocar, while said trocar passes through a wall of a patient’s body, the holder comprising:

at least one inflatable element extending around the trocar, which can be inflated to a predetermined size by a fluid source;

in which the specified source of fluid is located on the specified device of the holder of the trocar, thereby relying on it.

In accordance with a second aspect of the present invention, there is provided a trocar holder device for supporting a trocar, while said trocar passes through a wall of a patient’s body, said holder comprising:

at least one inflatable element extending around the trocar, which can be inflated to a predetermined size by a fluid source;

wherein said fluid source is a pumping mechanism forming part of said trocar holder and is manually controlled.

In accordance with a third aspect of the present invention, there is provided a trocar holder device for supporting a trocar, while said trocar passes through a wall of a patient’s body, said holder comprising:

at least one inflatable element extending around the trocar, which can be inflated to a predetermined size by a fluid source;

in which the specified source of fluid provides a fixed volume, allowing swelling only to a specified size.

Preferably, said inflatable member includes a cuff surrounding the trocar.

In one embodiment, the indicated trocar holder forms a monolithic structure with the trocar itself, so that they are supplied and used as a single element. however, since trocars are widely available and of various types, it is often more appropriate to provide the holder as a separate element, in most cases, in the form of a tube, so that the specified trocar can be inserted inside and mounted on the specified tube for insertion into the incision on the patient’s body .

Preferably, therefore, said trocar holder device comprises a separate element enabling attachment to the trocar and including a stop element having such a shape as to fit on the outer surface of the trocar tube, said stop element being arranged to be displaceable in the longitudinal direction along the tube a trocar for positioning in a selected position, wherein said at least one inflatable element is configured to be mounted on a trocar tube in a position spaced from said stop element, so that said at least one inflatable element in a deflated state can be placed on the tube of the trocar through an incision in the body wall and could be inflated when placed to come in contact with the inner surface of the body wall, and so that the specified stop element could be shifted to a position to maintain the body wall between this stop element and the specified at least one inflatable m element.

However, this trocar holder device can form an integral part of the trocar itself and be delivered as a composite structure.

In one design, said fluid source is supported by said abutment element. However, it can also rely on another component of the trocar holder, but as a part that is integral with it, so that the trocar holder entirely includes the necessary inflation device. This makes it possible to properly and easily control said pumping device to provide the required amount of pumping fluid.

Preferably, therefore, the fluid source is a manually operated pump. However, other single doses of fluid may be provided as part of the device.

Preferably, the tube connects the fluid source on the trocar holder to an inflatable cuff. The specified tube can be wrapped spirally around the tube of the trocar, so that its axial length along the trocar can be adjusted without stretching or affecting its operation.

Preferably, said tube has a circular cross-section, however, in some cases, it may have a flattened cross-section so as to fit against the tube of the trocar to allow said tube of the trocar to enter through the section without interference from the side of the tube.

Preferably, said inflatable cuff includes a portion of the tube that can be deployed along the tube of the trocar to engage around the tube of the trocar along the length of the trocar, to provide resistance to slipping along the trocar during insertion.

Preferably, said inflatable cuff and said stop element form a common cuff portion that can be engaged with the trocar tube and axially moved along it. Thus, at first they act as a single part applied to the outer surface of the trocar tube, and then they separate when deployment takes place.

Preferably, a plastic rigid support cuff is provided to support the soft inflatable cuff. The specified support cuff is attached to the stop element and is displaced along with it along the trocar tube. This support cuff is then removed from the stop element and the inflatable cuff when the specified inflatable cuff reaches its desired axial position.

Preferably, the support cuff includes a manually operated release member for disengaging said support cuff from the inflatable cuff.

Preferably, the support cuff includes a rigid protective cover for contacting a manually controlled fluid source element to prevent premature inflation.

Preferably, a manually operated device is provided on said support cuff for working with an inflatable cuff in a desired axial position to keep said inflatable cuff from axial displacement in a desired position on a trocar tube.

Preferably, said stop element can be axially displaced along the trocar tube from the inflatable cuff when the latter reaches its desired axial position, while said tube is stretched along the trocar tube as the stop element moves away from the inflatable cuff.

Preferably, the stop element comprises a sleeve clutch with a manual clip for engagement with the tube of the trocar.

Preferably, said fluid source includes a manually operated element that can be compressed to direct fluid to an inflatable cuff.

Preferably, a manually actuated device is provided for acting on an inflatable cuff in a desired axial position to keep said inflatable cuff from axial displacement in a desired position on a trocar tube.

The design may also include the aforementioned idea of providing a fluid source or pump on the device itself, so that the specified source provides a fixed volume that allows pumping only to a predetermined size.

In a preferred embodiment, a manually driven pump mechanism is integrated in the upper stop element. however, alternatively, said manually driven pump may be separate from the upper stop element, but still permanently connected to the lower inflatable cuff and delivering a fixed volume of fluid. And as another alternative, it can be attached to the specified stop element, but not necessarily built-in.

A design may also be provided in which a manually operated pump is part of the system but is not integrated into the stop element. a fundamental feature is that for the sake of safety, convenience and accuracy, it always provides the optimum volume of fluid required to fully pump the cylinder and always completely lower the specified cylinder. Excessive inflation can lead to rupture of the balloon while it is inserted into the patient’s body and the removal of the trocar, whereas if the balloon is involuntarily deflated only partially, this can result in significant damage to the patient. in addition, insufficient pumping may result in the trocar not being properly held during the procedure. In addition, the presence of an inherent fluid supply eliminates the need for an external fluid inlet, which may be confused with an existing external trocar opening. Medical personnel may accidentally plug in the wrong inlet, which will adversely affect the device and the entire procedure. In addition, the presence of an inherent fluid supply eliminates additional steps during which it is necessary to select an external fluid source and connect said external source. Finally, in the case where an external fluid source is required, there is a risk of selecting the wrong external source (or volume or fluid) that will adversely affect the device or procedure as a result of excessive pumping, insufficient pumping, or due to insufficient blowing.

Brief Description of the Drawings

One embodiment of the present invention will now be described in combination with the accompanying drawings, in which:

In FIG. 1 is a side view of a first embodiment of a trocar holder in accordance with the present invention, moreover, this view is shown partially in cross section.

FIG. 2 illustrates a top view of the embodiment of FIG. 1.

FIG. 3 illustrates a bottom view of the embodiment of FIG. 1.

In FIG. 4 is a side view of the embodiment of FIG. 1, which is shown mounted on the trocar and during operation.

FIG. 5-9 illustrate side views of the embodiment of FIG. 1, which demonstrate installation steps on a trocar.

In FIG. 10 is a side view of a second embodiment of a trocar holder in accordance with the present invention, moreover, this view is shown partially in cross section.

In FIG. 11 and 12 are side views of a third embodiment of a trocar holder in accordance with the present invention.

In the drawings, the same reference numerals denote the corresponding parts in various drawings.

Detailed description

FIG. 1-9 illustrate a trocar holder 10 for attachment to a trocar 12 in order to hold the tube 11 of the trocar 12 while the tube 11 penetrates the wall 13 of the patient’s body.

The specified holder 10 includes an element 14 of the emphasis, having such a shape as to fit on the outer surface of the tube of the trocar. Said abutment element forms a cuff 14A that surrounds said tube with a balancing clip 14B, manually actuated, for detachable connection with tube 11, for longitudinal displacement along the tube 11 of the trocar for positioning in a selected position 11A, as shown in FIG. 4.

The holder 10 includes an inflatable cuff 15 for placement on the tube 11 of the trocar in the desired position 15B, located at a distance from the stop element 14 in position 11A. The specified inflatable cuff can be pumped using a source of fluid, usually air or other gas, by means of a pump 17, to a predetermined size through the supply tube 16.

As shown in FIG. 9, the inflatable cuff in the deflated state can be placed on the trocar tube through an incision in the body wall and can be inflated after being introduced by pump 17 through the tube 16 to the inflated state shown in FIG. 4 at position 15B to come into contact with the internal the surface of the wall 13 of the body. The specified stop element can be shifted to position 11A in order to hold the body wall 13 between the stop element 14 and the inflatable cuff 15.

The fluid source provided by the pump 17 is placed on the trocar holder and, in particular, on the stop element 14, thereby relying on it. The pump 17 includes a manually-pressed button 17A that extends into the cylinder 17B to direct the measured volume of fluid to the inflatable cuff. The specified button 17A has a latch (not shown) that holds it pressed to maintain inflation until removal is required, as a result of which the specified latch can be unlocked by further pressing the button 17A to allow the spring 17C to push the button and remove the fluid cuff environment 15.

The fluid source, therefore, is a pumping mechanism forming part of the trocar holder and manually actuated. The source 17 of the fluid provides a fixed volume, allowing the inflation of the cuff 15 only to a predetermined size.

Tube 16 has a circular cross-section or, in some cases, a flattened cross-section to fit against the tube of the trocar, and is wrapped spirally around the tube of the trocar. Thus, it can lie in the form of compressed in a row of turns, as shown in the initial position in FIG. 1, and can be axially stretched, as shown in FIG. 9.

The inflatable cuff 15 includes a tube portion 15A extending downward from the lower edge of the cuff, which can be deployed along the tube of the trocar, as shown in FIG. 4. in the initial position shown in FIG. 1, the cuff and the specified section are folded into the structure for subsequent deployment.

As shown in FIG. 1, the inflatable cuff 15 and the stop element 14 form a common cuff portion 10, which can be engaged with the trocar tube 11 and axially moved along it from the lower insertion end to the desired position along the length of the trocar tube. In order to maintain the assembled device in a fixed and unchanged state for placement on the trocar, a support cuff 19 is provided that surrounds the inflatable cuff 15 attached to the stop element 14 and moves with it along the trocar tube. Said support sleeve includes a sleeve 19A with a hollow interior 19B that forms a protrusion 19C on which the sleeve 15 rests. This holds said sleeve in place, protects it and helps maintain its sterility by eliminating the need to touch the inflatable sleeve while the device is being installed in place. the support cuff 19 is configured to axially remove from the stop element and the inflatable cuff, toward the end of the trocar 11, when the inflatable cuff 15 reaches its desired axial position, as shown in FIG. 8. The support cuff 19 includes a manually actuated release member 19C, 19D for disengaging the support cuff 19 and the inflatable cuff 15. This is controlled by a lever 19D that holds the cuff 15 in place until the release is required, as a result of which the 19C actuated member a manual action is used to unlock the specified lever and in order to allow the cuff 15 to turn around and then the cuff 19 to move axially away from the cuff 15. as shown in FIG. 3, the element 19C may form a cam with protrusions 19E that locks the lever 19D until said protrusions rotate about the longitudinal axis 19F, releasing the lever and allowing the cuff 15 to deploy. the lever 19D may be spring loaded, which ensures that said lever, when opened, is turned away from the inflatable cuff. As an alternative to the cam structure described above, the element 19C may be a manually actuated push button that locks the lever 19D when pressed once and releases the lever when pressed again. When pressed, this button has a latch that holds it pressed. The specified latch is released by further pressing the button so that it can be pushed out by a spring.

the support cuff 19 is molded from a plastic material in order to be stiff to protect the inflatable cuff, and contains a protective coating 19G on one side forming a cover for enclosing the manually operated button 17A of the pump 17.

The stop element 14 can be axially displaced along the inflatable cuff 15 when the latter reaches its desired axial position 15B, while the tube 16 extends along the trocar tube as the stop element moves away from the inflatable cuff.

As shown in FIG. 10, a support device 19 is provided, if necessary, with a manually actuated device 19S using the button 19R to act on the inflatable sleeve 15 in the desired axial position 15B on the trocar to keep the inflatable sleeve 15 from axial displacement in the desired position 15B by tube of the trocar. This device 19S can operate using a variety of different techniques, as described below, in order to ensure that the cuff 15 remains in the desired position until pumping is more efficient.

Additional attention may be required with some designs to ensure that the inflatable cuff remains in place after the device is placed on the trocar and while the trocar is inserted into the incision in the wall of the patient. thus, for example, the following additional structures can be used as the manually actuated device 19S:

A portion of the material of the wound metal spring can be embedded inside or placed on the lower cuff of the inflatable stop. With the introduction of the trocar, the specified spring is forced to open, forcing the inflatable support to capture the wall of the shell of the trocar.

A round o-ring, a turn or a split ring can be crimped to the proper position using a crimping tool element included in the support sleeve of the device. The cam system is used to apply force to the metal elements that transmit this force to the outer diameter of the indicated round o-ring, coil or split ring, causing them to deform plastically, fixing the inflatable stop. Alternatively, a threaded sealed fitting system integrated in a support sleeve similar to that shown in FIG. 10 can be used to crimp said o-ring, coil or split ring to the desired position. The threaded lower portion of the supporting cuff is manually actuated by rotating it relative to the threaded upper portion of the supporting cuff, which causes them to close together and transmit force to the outer diameter of said round o-ring, coil or split ring, causing them to deform plastically, fixing inflatable stop element.

The support cuff of the device may be designed to keep the coil of spring / split ring open until the trocar is inserted into the desired position. Then the coil of the spring / split ring is released by applying the force of the spring to the lower cuff of the inflatable stop element, fixing it on the tube of the trocar.

The inner diameter of the elastic cuff of the inflatable stop may have an adhesive surface that is under a protective coating until ready for use. The removable support cuff of the device is designed to hold the inflatable cuff in a stretched open state. As soon as the adhesive is exposed and the trocar is placed in the desired position, the inflatable cuff is released.

the support cuff of the device may be designed to pull up the embedded thin wire or tape attached to the lower cuff of the inflatable stop element.

In addition, the design described herein can be modified as a series of alternative designs and variations that can be used as follows:

The fluid supply cylinder may be replaced by a chamber filled with a fluid that is compressed by a manually operated member;

Inflating the balloon will help to additionally fix the inflatable cuff to the tube of the trocar, as described above;

A spiral fluid supply channel spanning a trocar tube may be formed in the form of an oval or ribbon to allow for increased fluid flow rate with a smaller overall outer diameter when wrapped around the trocar;

the fluid supply channel connecting the upper and lower stop elements can be located vertically along the axis of the trocar, while the excessive length of the specified channel remains unsecured, since the upper stop is displaced in the direction of the lower stop.

Another option is the case where the upper stop contains a mechanism for self-retracting the excessive length of the fluid supply channel as the upper stop is displaced in the direction of the lower stop.

Larger trocars require a larger inflatable section and therefore need a larger amount of fluid to perform pumping. To satisfy this requirement, an additional cylinder or fluid supply chamber may be provided on the opposite side with respect to the existing fluid supply, if necessary;

Another approach is to use a self-opening fluid supply chamber that wraps around a portion of the trocar (inside the upper stop) and has sufficient volume to fully inflate the lower portion when fully compressed. This is a closed system containing the specified chamber, the fluid supply channel and the lower inflatable section;

Another option is to use a manual multi-stroke pump with an overflow valve to prevent over-inflation and an indicator to indicate when the lower section is fully inflated and fully deflated. Then the specified pump switches to reverse operation for pumping;

Another option may be provided in which a fluid delivery system is also used, but there is no system for retracting a fluid supply channel in the upper stop. In this case, the upper fluid supply is in a fixed position from the proximal end of the trocar tube, but the other cuff, which moves along the axis of the trocar tube, becomes the upper stop. The fluid supply channel is fully deployed all the time and is held in place along the outer surface of the trocar tube using a sheath.

the lever mechanism depicted in the upper part of the upper stop is used to fix the specified upper stop on the trocar by means of a cuff that is compressed around the trocar. An alternative is to replace this mechanism with a push button element for greater ease of use. The indicated button is located on the circumference of the upper stop element in the same way as the inflation pump is illustrated. By pressing this button, pressure is applied to the wall of the tube of the trocar, thus fixing it.

The device can also be installed on the trocar tube manually, using only the hand, without using a support cuff. The trocar is inserted into the device, and the inflatable cuff is pulled along the axis of the trocar tube and unfolds on the trocar tube with the hand in the desired position.

Another trocar idea may be proposed that is significantly different in form, but also uses a fixed volume fluid delivery system. The fluid delivery system is fixed in position from the proximal end of the trocar tube and inflates ribs or rings along the length of the trocar tube when it is in the desired position. said rings may also consist of solid elements that are pneumatically actuated to protrude from the wall of the trocar tube and are removed when the trocar tube is to be removed. In another design, there may be a control device, under the control of which these rings are pumped or actuated. in this case, there is no upper or lower stop element.

It is also possible to attach the inflatable stop element to the trocar without the need to roll it. In this case, there are three design options:

a) The supporting cuff of the device may be designed in such a way that the front edge of the deployed inflatable stop element is held open until the trocar is placed in the desired position. The trocar is then pushed into the hole and pushed to the desired location. when the trocar is in the desired position, the hole is released.

b) The supporting cuff of the device has means for maintaining the entire deployed inflatable stop element in its entirety open, until the trocar is placed in the desired position. Then the inflatable stop element is released, fixing in the right position on the tube of the trocar.

c) A disposable tubular frame is used to hold the inflatable stop element open until the trocar is placed in the desired position. when the trocar is in the required position, the indicated disposable frame is removed, leaving the inflatable stop element on the outer diameter of the trocar tube. This is achieved with or without the aid of a cuff-supporting device. when using a support cuff, said frame engages with a support cuff. If a support cuff is not used, the frame engages with the device itself either at the base of the upper stop element or through channels contained within the inner diameter of the upper stop element.

In FIG. 11 and 12 are side views of a third embodiment of a trocar holder, in accordance with the present invention, where the trocar holder is an integral part of the trocar itself.

In this case, also, there is no separate inflatable cuff, but instead the trocar itself has a number of inflatable rings.

Therefore, FIG. 11 and 12 respectively illustrate a trocar 100 with a trocar rod 102 having a tip 105 for insertion through an incision in a wall 106 of a patient’s body. said trocar rod has a series of rings 101 formed on the outer wall, which can extend annularly around the rod or in a spiral along the rod and act to place the trocar rod inside the section. As described above, a stop 103 is provided at the end of the rod for engagement with the outer wall 106, wherein said stop comprises a hand pump 104 for pumping the rings 101. Therefore, as described above, the fluid source is located on the device of the trocar holder in order to lean on It is provided by a pumping mechanism that forms part of the trocar holder and is manually actuated, and the fluid source provides a fixed volume that allows pumping only to a specified size.

This design is more convenient for the surgeon to insert and remove from the patient’s body than traditional designs of this type, where the protrusions have actually large threads and the trocar tube must be screwed in and out of the incision and fascia. rotational movement during insertion and extraction of a traditional threaded trocar can injure the fascia. The described construction is intended to contact the fascia itself after insertion, thereby preventing potential damage to the fascia from rotational movement.

In this design, inflation is carried out by means of an inflating hand pump of the type described above, which relies on the cuff part of the trocar itself. This controls the amount of fluid used and eliminates the need for a separate fluid source.

Claims (16)

1. a trocar holder device for supporting a trocar having a trocar tube, while said trocar passes through a wall of a patient’s body, comprising a separate element enabling attachment to the trocar, and comprising: an emphasis element having such a shape as to fit on the outer surface of the trocar tube, moreover, the emphasis element is arranged with the possibility of alignment in the longitudinal direction along the tube of the trocar for location in the selected position; at least one inflatable element extending around the tube of the trocar, which can be pumped to a predetermined size by a source of fluid; moreover, at least one inflatable element is made with the possibility of installation on the tube of the trocar in a position spaced from the specified stop element, so that the specified at least one inflatable element in a deflated condition can be mounted on the tube of the trocar through an incision in the body wall and can be inflated when mounted, for engagement with the inner surface of the body wall and so that said stop element can be shifted to a position to maintain the body wall between this stop element and said at least one inflatable element; moreover, the source of the fluid is configured to provide a fixed volume that allows pumping only to a specified size; moreover, the fluid source contains a manually compressible pump located on the tube of the trocar; moreover, the pump contains a latch configured to hold the pump in a compressed state to maintain inflation until removal is required until the latch is unlocked; and and provided with a spring made with the possibility of providing a reverse stroke of the pump and extracting fluid from the inflatable element when the lock is released. 2. The trocar holder device according to claim 1, wherein the tube connects a fluid source on the trocar holder to said at least one inflatable member. 3. The trocar holder device according to claim 2, wherein said tube is wrapped spirally around the trocar tube. 4. The device of the trocar holder according to claim 1, in which the specified fluid source is configured to rely on the specified stop element. 5. The trocar holder device according to claim 1 or 4, wherein said at least one inflatable element and said stop element form a common portion of the cuff that can be engaged with the trocar tube and axially moved along it. 6. The trocar holder device according to claim 1, wherein a supporting cuff is provided for said at least one inflatable element, which is attached to a stop element and is movable with it along the trocar tube, and wherein said supporting cuff is removable from an abutment member and said at least one inflatable member when said at least one inflatable member reaches its desired axial position. 7. The trocar holder device according to claim 6, wherein the support cuff includes a manually operated release member for disengaging said support cuff from said at least one inflatable member. 8. The trocar holder device according to claim 1, in which the stop element comprises a cuff with a manual clip for engagement with the trocar tube.

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